A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
Public ClinicalTrials.gov record NCT05952869. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Study identification
- NCT ID
- NCT05952869
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 303 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 8, 2023 (Actual)
- Primary completion
- Apr 7, 2025 (Actual)
- Completion
- Apr 7, 2025 (Actual)
- Last update posted
- Feb 24, 2026
2023 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC ( Site 0023) | Daphne | Alabama | 36526 | — |
| Excel Medical Clinical Trials ( Site 0008) | Boca Raton | Florida | 33434 | — |
| Advanced Pharma Research ( Site 0007) | Cutler Bay | Florida | 33189 | — |
| Progressive Medical Research ( Site 0021) | Port Orange | Florida | 32127 | — |
| Clinical Site Partners LLC, dba CSP Orlando ( Site 0028) | Winter Park | Florida | 32789 | — |
| Synexus Clinical Research US - Evansville ( Site 0031) | Evansville | Indiana | 47714 | — |
| Franciscan Physician Network - Indiana Heart Physicians ( Site 0040) | Indianapolis | Indiana | 46237 | — |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001) | Troy | Michigan | 48098 | — |
| Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026) | Lincoln | Nebraska | 68506 | — |
| Jubilee Clinical Research ( Site 0030) | Las Vegas | Nevada | 89106 | — |
| Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041) | Winston-Salem | North Carolina | 27157 | — |
| Velocity Clinical Research, Salt Lake City ( Site 0004) | West Jordan | Utah | 84088 | — |
| Health Research of Hampton Roads, Inc. ( Site 0020) | Newport News | Virginia | 23606 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05952869, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05952869 live on ClinicalTrials.gov.